Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance

This study has been completed.
Sponsor:
Information provided by:
Arete Therapeutics
ClinicalTrials.gov Identifier:
NCT00847899
First received: February 17, 2009
Last updated: November 18, 2009
Last verified: November 2009
  Purpose

The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with impaired glucose tolerance and mild to moderate hypertension.


Condition Intervention Phase
Hypertension
Impaired Glucose Tolerance
Drug: AR9281
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Exploratory, 28-Day Study to Examine the Effects of AR9281 on Blood Pressure and Glucose Tolerance in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance

Resource links provided by NLM:


Further study details as provided by Arete Therapeutics:

Primary Outcome Measures:
  • Systolic and Diastolic blood pressure [ Time Frame: 28 day treatment period ] [ Designated as safety issue: No ]
  • Glucose dynamics and insulin sensitivity [ Time Frame: 28 day treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
AR9281
Drug: AR9281
AR9281 taken in BID dosing regimen for 28 days
Active Comparator: 2
AR9281
Drug: AR9281
AR9281 taken in TID dosing regimen for 28 days
Placebo Comparator: 3
Placebo
Drug: Placebo
Placebo taken in BID dosing regimen for 28 days
Placebo Comparator: 4
Placebo
Drug: Placebo
Placebo taken in TID dosing regimen for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mild to moderate hypertension
  • naive to antihypertensive medication or on two or less antihypertensive medications
  • impaired glucose tolerance
  • mild obesity

Exclusion Criteria:

  • Diagnosis of Type 1 or Type 2 diabetes
  • History of severe heart failure
  • AST, ALT levels more than twice the normal range
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847899

  Hide Study Locations
Locations
United States, Alabama
Arete Investigational site
Mobile, Alabama, United States, 36617
Arete Investigational site
Muscle Shoals, Alabama, United States, 35662
United States, California
Arete Investigational site
Anaheim, California, United States, 92801
Arete Investigational site
Concord, California, United States, 94520
Arete Investigational site
Mission Hills, California, United States, 91345
United States, Florida
Arete Investigational site
Bradenton, Florida, United States, 34203
Arete Investigational site
Deland, Florida, United States, 32720
Arete Investigational site
Jacksonville, Florida, United States, 32216
Arete Investigational site
Largo, Florida, United States, 33770
Arete Investigational site
Miami, Florida, United States, 33169
Arete Investigational site
New Port Richey, Florida, United States, 34652
Arete Investigational site
Pembroke Pines, Florida, United States, 33026
Arete Investigational site
Port Orange, Florida, United States, 32127
Arete Investigational site
Tampa, Florida, United States, 33606
United States, Georgia
Arete Investigational site
Marietta, Georgia, United States, 30066
United States, Illinois
Arete Investigational site
Addison, Illinois, United States, 60101
United States, Kentucky
Arete Investigational site
Louisville, Kentucky, United States, 40213
United States, Massachusetts
Arete Investigational site
Brockton, Massachusetts, United States, 02301
United States, Michigan
Arete Investigational site
Paw Paw, Michigan, United States, 49079
United States, Nevada
Arete Investigational site
Las Vegas, Nevada, United States, 89123
United States, Ohio
Arete Investigational site
Cincinnati, Ohio, United States, 45219
Arete Investigational site
Cincinnati, Ohio, United States, 45245
Arete Investigational site
Marion, Ohio, United States, 43302
Arete investigational site
Mt. Gilead, Ohio, United States, 43338
United States, Oklahoma
Arete Investigational site
Oklahoma City, Oklahoma, United States, 73132
United States, Oregon
Arete Investigational site
Eugene, Oregon, United States, 97404
United States, Texas
Arete Investigational site
Austin, Texas, United States, 78704
Arete Investigational site
Dallas, Texas, United States, 75251
Arete Investigational site
San Antonio, Texas, United States, 78229
United States, Utah
Arete Investigational site
Orem, Utah, United States, 84058
Sponsors and Collaborators
Arete Therapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Calvert Lee, Sr. CRA, Arete Therapeutics
ClinicalTrials.gov Identifier: NCT00847899     History of Changes
Other Study ID Numbers: AR9281-CLN-003
Study First Received: February 17, 2009
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Arete Therapeutics:
hypertension
impaired glucose tolerance
s-EH enzyme inhibition
pre-diabetes

Additional relevant MeSH terms:
Hypertension
Glucose Intolerance
Vascular Diseases
Cardiovascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014